Advanced Dissolution Tester Sampling System — QualiPharma™ DIS SA 2014

Advanced Dissolution Tester Sampling System — QualiPharma™ DIS SA 2014 Key Features

Enhanced Dissolution Vessel Design

• Embedded fixing hoop dissolution vessel design: achieves superior centering and verticality of the dissolution vessel compared to conventional designs — indicator strips and diagonal cup-rim fixtures further improve reproducibility across vessels and test sessions
• Available vessel volumes: 1,000 mL (standard) and 250 mL (small cup method) — both transparent and low-actinic red versions available for photosensitive drug dissolution testing
• V-cup cover: contoured cover fits closely with the dissolution vessel to minimize dissolution medium evaporation during extended dissolution test runs
• Automatic dosing module with anti-sticking design: prevents tablet or capsule adhesion to the dosing delivery surface; supports simultaneous and sequential dosing to all vessels

Advanced Mechanical Architecture

• Segmented 316L stainless steel propeller shaft: when replacing, only the lower shaft section requires replacement — no full-shaft removal or height re-adjustment needed; reduces replacement workload and eliminates height setting errors after maintenance
• Multi-point stainless steel guide rod machine head: ensures rigidity and positional stability of the machine head across extended dissolution testing sessions — effectively prolonging the stable mechanical performance period of the instrument
• One-piece injection-molded water bath with quick-connect adapter: no internal bonding joints or right-angle dead zones — the smoothest water bath interior design for the most effective cleaning and decontamination between dissolution test campaigns

Autosampler & Sampling System

• Imported syringe pump autosampler: precisely controls all sampling steps — automatic rinsing, filling, waste drop disposal, sampling, replenishment, dilution, emptying, and post-run cleaning — zero manual sample handling required
• Imported PTFE micro-transparent pipelines: anti-corrosion and anti-adsorption properties minimize API binding to pipeline walls, ensuring sample integrity and accurate dissolution test results
• Automatic pipeline and sampler pre-rinsing before each sampling event: eliminates carryover contamination between time points
• Secondary filtration interface: provides enhanced particulate filtration for samples with higher particle loads — ensures cleaner samples for direct HPLC or UV-Vis injection
• Continuous sampling, dual-sample collection, and automatic sample dilution: minimum sampling interval 2 minutes; supports the most demanding multi-point dissolution test schedules
• Automatic sampling height calculation: software calculates the correct pharmacopeially specified sampling depth based on current solvent volume, ensuring pharmacopeia-compliant sampling position at every time point regardless of volume changes due to sampling or replenishment
• Sample collection rack: 2 mL HPLC injection vials × 128 positions or 15 mL test tubes × 128 positions
• One-click post-run automatic cleaning of liquid tank and pipelines: complete decontamination after each dissolution testing session to prevent cross-contamination

Software, Data Integrity & Compliance

• 10-inch color touchscreen: intuitive operator interface with bilingual (English/Chinese) operating menus and screen-lock security function
• 100 onboard method storage capacity: complete dissolution method parameters stored and named; one-click USB export/import for method transfer between instruments without manual re-entry
• 39 user accounts with three-tier access control: administrator, advanced user, and operator levels; administrator manages all account assignments and permission modifications centrally
• Eight independent real-time temperature monitoring probes: one per vessel; individual vessel temperatures continuously displayed and logged throughout each dissolution test run
• PID + fuzzy control temperature management: ≤±0.2°C accuracy, 0.1°C resolution
• Built-in printer: prints experimental data and operation records in real time
• Audit trail with log recording: full instrument operation logs with account identity, operation type, and timestamp; stored on instrument, can be encrypted for export, cannot be modified or deleted — supports 21 CFR Part 11 requirements
• Photosensitive lighting: white light and red light with adjustable brightness; red light automatically activates for photosensitive dissolution testing sessions
• AIQ certification services: manufacturer provides IQ/OQ/PQ documentation, mechanical verification certificates, and on-site installation/training support for U.S. and Canadian customers